Warnings, Recalls, and Safety Information: Drugs and Medical Devices (2023)

  • Class 4 Drug Shortage Information: Drugsrus Limited / Dawa Limited, Metronidazole Oral Suspension 200mg/5ml, EL(23)A/19

    Drugsrus Limited has notified the MHRA that a small number of 100ml bottles of metronidazole 200mg/5ml oral suspension are leaking from the cap.

    • Medical Specialty: General Practice Surgeries, +1 more
    • Published:
  • Security announcements in the field: 15.-19. May 2023

    List of Field Safety Notices (FSN) from May 15 to 19, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • Class 4 Drug Defect Information: Orifarm UK Ltd, Buccolam 10mg Oral Solution, EL(23)A/18

    Orifarm UK Ltd informed the MHRA that the Buccolam 10 mg buccal solution lot contains no information on the need to break the inner pack seal before use.

    • Medical specialty: anesthetics and 22 others
    • Published:
  • National Patient Safety Alert: Philips Health Systems V60 and V60 Plus Ventilator Recall: Risk of Disconnection Resulting in Total Loss of Ventilation (NatPSA/2023/005/MHRA)

    The MHRA issues updated recommendations that the Philips Respironics V60 and V60 Plus non-invasive ventilators should be permanently withdrawn from use.

    • Alert Type: National Patient Safety Alert
    • Medical specialty: anesthetics, +2 more
    • Published:

  • Novartis Pharmaceuticals has notified the MHRA that the solvent (Water for Injection in Ampoules) together with impacted batches of Simulect Powder for Injection may contain glass fragments approximately 20 to 800 µm in size and...

    • Medical Specialty: General Practice Surgeries, +1 more
    • Published:
  • Field Safety Notices: 8.-12. May 2023

    List of Field Safety Notices (FSN) from May 8 to 12, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • Safety notices in the field: 1.-5. May 2023

    Field Safety Notice List (FSN) for May 1-5, 2023.

    • Alert Type: Field Safety Alert
    • Published:

  • Hikma Farmacêutica Portugal S.A has notified the MHRA of a possible problem affecting the batches listed in this notice.

    • Medical Specialty: General Practice Surgeries, +1 more
    • Published:
  • National Patient Safety Alert: Class 1 Drug Recall Notice: Recall of Emerade 500 micrograms and Emerade 300 micrograms auto-injectors due to possible device failure, NatPSA/2023/004/MHRA

    Pharmaswiss Czech Republic s.r.o. is initiating an emergency recall of all lots of Emerade 500 micrograms and Emerade 300 micrograms autoinjectors.

    • Alert Type: National Patient Safety Alert
    • Medical specialty: anesthetics and 22 others
    • Published:
  • Alert Search Field Security Notices: April 24-28, 2023

    Field Safety Notification List (FSN) from April 24 to 28, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • Field Safety Advisories: April 17-21, 2023

    Field Safety Notice List (FSN) for April 17-21, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • Class 4 Drug Shortage Information: Omega Pharma Ltd, Beconase Hay Fever Nasal Spray, EL(23)A/15

    Omega Pharma Ltd has identified missing text in Section 2 of the Patient Information Leaflet (PIL) on Beconase hay fever (P) nasal spray cartons.

    See Also
    Clexane 20mg Injection: See how to use, side effects, prices and substitutes | 1mgA retrospective study of the epidemiological correlates of food, drug, and chemical poisoning in Al-Baha, western Saudi Arabia.★ Clexane solution for injection 20 mg/0.2 ml from Mexico 🥇Clexane multidose vial - Patient Information Leaflet (PIL)

    • Medical Specialty: General Practice Surgeries, +1 more
    • Published:
  • Class 4 Drug Shortage Information: Sandoz Limited, Co-amoxiclav 125/31.25mg/5ml, 250/62.5mg/5ml Powder for Oral Suspension, EL(23)A/14

    Sandoz Limited has notified the MHRA that the products referred to in this notice are not sugar-free, despite the fact that the packaging says 'sugar-free'. In December 2008, the 'sugar free' label was mistakenly added to the packaging.

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Company Led Drug Recall: Spectrum Therapeutics UK, Canopy AKH 22 Seca Cannabis 5g [Unlicensed Drug], CLMR (23)A/04

    The importer and distributor of the above products informed us of reports that the microbial limit for total aerobic microbial count (TAMC) exceeded the predefined limit of 200 CfU/g per product...

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Field safety notices: 10.-14. April 2023

    Field Safety Advisory List (FSN) for April 10-14, 2023

    • Alert Type: Field Safety Alert
    • Published:
  • NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Lifted Suspension, DSI 2023/006

    The MHRA has carried out a comprehensive assessment of the technical and biosafety information provided by NSO and is satisfied with the PRECICE Titanium subset of devices (Intramedullary Limb Lengthening (IMLL), Short, Unyte…

    • Alert Type: Device Security Information
    • Medical specialty: anesthetics, +6 more
    • Published:
  • Field Safety Advisories: April 3-7, 2023

    Field Safety Notice List (FSN) for April 3-7, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution from Carnamedica (UKRP: Bridge to Life): Fluid Contamination (Update DSI/2023/002), DSI/2023/005

    The MHRA provides an update on defects identified with Belzer's solutions, which are manufactured by Carnamedica (responsible for Bridge to Life in the UK).

    • Alert Type: Device Security Information
    • Medical specialties: intensive care and 7 others
    • Published:
  • Field Safety Advisories: March 27-31, 2023

    Field Safety Notice List (FSN) for March 27-31, 2023.

    • Alert Type: Field Safety Alert
    • Published:

  • Ethigen Limited notified the MHRA that the Patient Information Leaflet (PIL) for Briviact 75 mg and Briviact 100 mg film-coated tablets contained incorrect or missing information.

    • Medical Specialty: General Practice Surgeries, +1 more
    • Published:
  • Field Safety Advisories: March 20-24, 2023

    Field Safety Notification List (FSN) for March 20-24, 2023

    • Alert Type: Field Safety Alert
    • Published:
  • Class 2 Recall: Ferring Pharmaceuticals Limited, GONAPEPTYL Depot 3.75 mg, powder and solvent for suspension for injection, EL(23)A/12

    Ferring Pharmaceuticals Limited is recalling certain lots of GONAPEPTYL Depot 3.75mg due to a perceived flaw in the package seal of the CE marked 30mm subcutaneous injection needle (30mm) which...

    • Medical Specialty: General Practice Surgeries, +1 more
    • Published:
  • Safety notices in the field: 13.-17. March 2023

    Field Safety Advisory List (FSN) for March 13-17, 2023

    • Alert Type: Field Safety Alert
    • Published:
  • Class 3 Withdrawal: Rosemont Pharmaceuticals Limited, Sildenafil 10 mg/ml Oral Suspension, EL(23)A/11

    Rosemont Pharmaceuticals Limited has notified the MHRA that the pressurized bottle adapter (PIBA) supplied with the pack (box) of a particular lot is too large to fit the neck of the medicine bottle.

    • Medical Specialty: General Practice Surgeries, +1 more
    • Published:
  • Field Safety Advisories: March 6-10, 2023

    Field Safety Notice List (FSN) for March 6-10, 2023.

    See Also
    Clexane 40 mg injection (0.4 ml each): see how to use, side effects, prices and substitutes | 1mgHow to inject enoxaparin at homeClexane PREVENTIS Prefilled Syringes Needle Guard Safety System - Patient Information Leaflet (PIL)IVF delivers 'miracle' babies for Derry couple

    • Alert Type: Field Safety Alert
    • Published:
  • Class 4 Drug Shortage Information: Macarthys Laboratories t/a Martindale Pharma, Venlafaxine XL 150mg, 225mg, 300mg Extended Release Tablets, EL(23)A/10

    In addition to the batches included in the Class 4 Drug Notification above (reference EL(22)A/47), Martindale Pharma notified the MHRA that the GTIN in the 2D barcode and printed variable data represent...

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Withdrawal of class 2 medicines: various marketing authorization holders, pholcodine-containing products, EL (23)A/09

    After the MHRA completes a post-marketing safety review, all pholcodine-containing medicines will be withdrawn from the UK as a precaution.

    • Medical specialty: anesthetics and 22 others
    • Published:
  • Class 4 Drug Shortage Information: Drugsrus Limited, Clexane 10,000 IU (100 mg) / 1 ml syringe, EL(23)A/08

    The MHRA was notified by Drugsrus Limited that the special batch packaged Patient Information Leaflet (PIL) of Clexane 10,000 IU (100mg)/1ml syringes contained a typographical error in the package leaflet.

    • Medical specialty: general medicine offices and 2 others
    • Published:

  • Thornton & Ross Ltd notified the MHRA that certain lots of Methadone 1 mg/mL Oral solution BP Sugar Free and Methadone Mixture 1 mg/mL were packaged with an incorrect Product Information Leaflet (P...

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Field Safety Notices: February 27 - March 3, 2023

    Field Safety Notice List (FSN) from February 27 to March 3, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • Field Safety Advisories: February 20-24, 2023

    Field Safety Notice List (FSN) for February 20-24, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • Class 2 Drug Recall: Teva UK Limited, Levothyroxine 12.5mcg Tablets, EL(23)A/06

    Teva UK Limited is recalling a batch of levothyroxine 12.5 mcg tablets in response to a sub-required assay result detected during routine stability testing.

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Company Led Drug Recall: Vertical Pharma Resources Ltd T/A IPS Pharma, Levothyroxine Oral Suspension (Various Strengths) [Unlicensed Drug], CLMR(23)A/03

    IPS Pharma is recalling certain lots of levothyroxine oral suspension from affected pharmacies and patients because the concentration of levothyroxine is higher than the amount indicated on the label.

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Class 4 Medicine Shortage Information: Atnahs Pharma UK, Zestoretic Tablets 20mg/12.5mg, EL(23)A/05

    Atnahs Pharma UK has notified the MHRA that the Patient Information Leaflet (PIL) packaged with certain batches of Zestoretic 20mg/12.5mg tablets contains out-of-date safety information.

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Class 4 Drug Shortage Information: Reckitt Benckiser Healthcare (UK) Limited, Lemsip Max Cold and Flu Capsules, EL (23)A/04

    Reckitt Benckiser Healthcare (UK) Limited has notified the MHRA that a typographical error has been identified on the outer carton lid of some batches of Lemsip Max Cold & Flu capsules.

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Field Safety Advisories: February 13-17, 2023

    Field Safety Notification List (FSN) from February 13 to 17, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • BD BodyGuard MicroSets and Residual Ethylene Oxide: Devices can continue to be used to treat pediatric patients weighing 5 kg or more, DSI/2023/004

    As a precautionary measure, following an evaluation by the MHRA of currently available data on OE levels, alternative devices to BD BodyGuard Microsets should be sought in users weighing 5 kg or less.

    • Alert Type: Device Security Information
    • Medical specialty: anesthetics, +6 more
    • Published:
  • NexGen Knee Replacement: Affected Patients Should Receive Additional Follow-Up, DSI/2023/003

    El National Joint Registry (NJR) ha determinado que ambos componentes tibiales NexGen® Stemmed Option, combinados con Legacy® Posterior Stabilized (LPS) Flex Option Femoral o LPS Flex Gender Solutions Fem...

    • Alert Type: Device Security Information
    • Medical specialty: Family home, +2 more
    • Published:
  • Field Safety Advisories: February 6-10, 2023

    Field Safety Notice List (FSN) for February 6-10, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • Field Safety Notices: January 30 - February 3, 2023

    Field Safety Notice List (FSN) from January 30 to February 3, 2023.

    • Alert Type: Field Safety Alert
    • Published:
  • National Patient Safety Alert: Pre-Fitted NIDEK EyeCee One and Pre-Fitted EyeCee One Crystal Intraocular Lens (IOL): Risk of Increased Intraocular Pressure (NatPSA/2023/003/MHRA)

    The MHRA is aware of cases of increased intraocular pressure in patients recently implanted with EyeCee One Preloaded and EyeCee One Crystal intraocular lenses (IOLs), manufactured by NIDEK and distributed by...

    • Alert Type: National Patient Safety Alert
    • Medical specialty: ophthalmology
    • Published:
  • Belzer UW Cold Storage Solution and Belzer MPS UW Machine Perfusion Solution manufactured by Carnamedica (UKRP: Bridge to Life): Contamination of fluids; DSI/2023/002

    Carnamedica has identified issues with third-party vendors that can lead to microbial contamination, particulates in solution, and fluid leaks.

    • Alert Type: Device Security Information
    • Medical specialty: Intensive care and 6 others
    • Published:
  • Field Safety Notice (FSN) January 23-27, 2023

    Field Safety Advisories (FSN) for January 23-27, 2023

    • Alert Type: Field Safety Alert
    • Published:
  • Field Safety Advisory: January 26, 2023

    Field Safety Notices (FSN) dated January 26, 2023.

    • Alert Type: Field Safety Alert
    • Medical Specialty: General Practice and 2 Ph.D.
    • Published:
  • EyeCee One Preloaded Intraocular Lenses (IOL) and EyeCee One Crystal Preloaded: Immediately discontinue use and quarantine all EyeCee One Preloaded IOL DSI/2023/001

    The MHRA is aware of reports of increased intraocular pressure in patients who recently received EyeCee One and EyeCee One Crystal intraocular lenses (IOLs).

    • Alert Type: Device Security Information
    • Medical specialty: ophthalmology
    • Published:
  • Company Led Withdrawal from the Market: Prulab Pharma Limited, Clopidogrel Oral Solution 75mg in 5ml [Unlicensed Medicinal Product], CLMR(23)A/02

    Prulab Pharma Limited is recalling one lot of clopidogrel oral solution 75mg in 5ml due to inconsistencies with product packaging instructions, which may result in the wrong volume being administered to the patient.

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Class 3 drug recall: Dr. Reddy's Laboratories (UK) Ltd, Lacidipine 4 mg film-coated tablets, EL (23)A/03

    A doctor. Reddy's Laboratories (UK) Limited is recalling two lots of Lacidipine 4 mg film-coated tablets as a precautionary measure due to the presence of an unknown solvent odour.

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Class 2 Withdrawal: UCB Pharma Ltd, Dioctyl 100 mg capsules, EL (23)A/02

    UCB Pharma Ltd is recalling a batch of Dioctyl 100mg capsules from the market as a precautionary measure due to the presence of a foreign capsule in the sealed pack.

    • Medical specialty: general medicine offices and 2 others
    • Published:
  • Field Safety Advisories: January 9-13, 2023

    Field Safety Notice List (FSN) for January 9-13, 2023.

    • Alert Type: Field Safety Alert
    • Published:

  • Certain batches of products are being recalled as a precautionary measure because validation tests show leaching of filter additives to be above acceptable limits.

    • Medical Specialty: General Practice Surgeries, +1 more
    • Published:
Top Articles
Latest Posts
Article information

Author: Moshe Kshlerin

Last Updated: 04/23/2023

Views: 6444

Rating: 4.7 / 5 (77 voted)

Reviews: 84% of readers found this page helpful

Author information

Name: Moshe Kshlerin

Birthday: 1994-01-25

Address: Suite 609 315 Lupita Unions, Ronnieburgh, MI 62697

Phone: +2424755286529

Job: District Education Designer

Hobby: Yoga, Gunsmithing, Singing, 3D printing, Nordic skating, Soapmaking, Juggling

Introduction: My name is Moshe Kshlerin, I am a gleaming, attractive, outstanding, pleasant, delightful, outstanding, famous person who loves writing and wants to share my knowledge and understanding with you.